ZEOBI

K121338 · Ivivi Health Science, LLC · ILX · Jul 27, 2012 · Physical Medicine

Device Facts

• Record ID: K121338
• Device Name: ZEOBI
• Applicant: Ivivi Health Science, LLC
• Product Code: ILX · Physical Medicine
• Decision Date: Jul 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

Device Story

Zeobi is a portable, battery-powered, non-invasive therapy device. It applies electromagnetic energy at a 27.12 MHz radio frequency to tissue via inductive coupling with an applicator coil. It operates by athermal means, avoiding deep heat generation. The device is used for palliative treatment of post-operative pain and edema. It can be applied directly through dressings, clothing, casts, compression garments, or supports. The device features an LCD display and offers both automatic and manual treatment modes. It is intended for use as an adjunct to other treatments.

Clinical Evidence

No clinical data was necessary to support substantial equivalence. Evidence consists of bench testing, including verification and validation of carrier frequency, burst duration, burst repetition, and energy density using calibrated probes, oscilloscopes, and spectrum analyzers in a validated saline load.

Technological Characteristics

Portable, battery-powered device. Emits 27.12 MHz RF energy via inductive coupling. Conforms to IEC 60601-1 (General Safety) and IEC 60601-1-2 (EMC). Features a multi-function LCD display and detachable battery pack. Operates in automatic or manual modes with a 15-minute maximum treatment time.

Indications for Use

Indicated for adjunctive palliative treatment of post-operative pain and edema in superficial soft tissue.

Regulatory Classification

Identification

A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.

Special Controls

*Classification: Class II (special controls).* The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. (ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined: (A) Peak output power; (B) Pulse width; (C) Pulse frequency; (D) Duty cycle; (E) Characteristics of other types of modulation that may be used; (F) Average measured output powered into the RF antenna/applicator; (G) Specific absorption rates in saline gel test load or other appropriate model; (H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and (I) Characterization of the deposited energy density in saline gel test load or other appropriate model. (iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use. (v) Labeling must include the following: (A) Output characteristics of the device; (B) Recommended treatment regimes, including duration of use; and (C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications. (vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.

Predicate Devices

• SofPulse Torino II (K070541)

Submission Summary (Full Text)

{0}------------------------------------------------

A final order reclassifying shortwave diathermy (SWD) intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues, a preamendments Class III device, into class II, and renaming the device "nonthermal shortwave therapy" (SWT), was published on October 13, 2015. See here:

https://www.federalregister.gov/documents/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwavediathermy-for-all-other-uses-henceforth-to

While the device submitted and cleared through K121338 may serve as a valid predicate device for a new SWT device, please refer to the aforementioned final order for current regulatory requirements for this device type.

{1}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized depiction of an eagle. The eagle is shown with its wings spread, symbolizing protection and service.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ivivi Health Sciences, LLC % Ms. Kathryn Clubb President & CEO 330 Townsend Street, Suite 100 San Francisco, California 94107

Re: K121338

Trade/Device Name: Zeobi Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: Class III Product Code: ILX Dated: June 27, 2012 Received: June 29, 2012

JUL 2 7 2012

#### Dear Ms. Clubb:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encrease of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , morely misions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Thease now, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I coloral statutes and regisments, including, but not limited to: registration and listing (21

{2}------------------------------------------------

### Page 2 - Ms. Kathryn Clubb

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark A. Mckenna

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# 4. Indications for Use Statement

Indications for Use 510(k) Number (if known): _________

Device Name: Zeobi

Indications for Use: Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

oncurrence of CDRH, Office of Device Evaluation (ODE)

---

(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121338

16

{4}------------------------------------------------

# 510(k) Summary

. .

:

:

:

.

-

### Zeobi: Special 510k Summary

JUL 2 7 2012

: ·

.

| Submitter: | Ivivi Health Sciences LLC<br>330 Townsend Street, Suite 100<br>San Francisco, California 94510<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kathryn Clubb<br>President and CEO<br>Office phone: [phone] |
| Date Summary Prepared: | June 27, 2012 |
| Device Trade Name: | Zeobi |
| Common Name: | Shortwave diathermy |
| Classification Name: | 890.5290(b) Shortwave diathermy for use other than applying<br>therapeutic deep heat |
| Product Code | ILX |
| Classification Code: | A shortwave diathermy for all other uses except for the<br>treatment of malignancies is a device that applies to the body<br>electromagnetic energy in the radio frequency bands of 13<br>megahertz to 27.12 megahertz and that is intended for the<br>treatment of medical conditions by means other than the<br>generation of deep heat within body tissues. |
| Equivalent Device: | SofPulse Torino II (K070541) |
| Device Description: | The Zeobi is a portable battery powered non-invasive therapy<br>device which applies to the body electromagnetic energy at a<br>radio frequency (RF) of 27.12 MHz for the treatment of medical<br>conditions by means other than the generation of deep heat<br>within body tissues, i.e., by athermal means. The Zeobi was<br>designed to deposit mean radio frequency energy in tissue<br>which is equivalent to that of the Torino II. The Zeobi delivers<br>the RF signal to the tissue target via inductive coupling with an<br>applicator coil. The device is portable and treatment can occur<br>directly through dressings, clothing, casts, compression<br>garments or supports. |
| Nonclinical Performance<br>Data: | This Special 510(k) contains the risk assessment and a summary<br>of verification/validation testing to support the three requested<br>modifications. |

23

.

{5}------------------------------------------------

Clinical Performance Data:

Clinical data was not determined to be necessary to support the substantial equivalence for the three modifications requested in this Special 510(k).

Comparison:

| Device Features | Predicate<br>Torino II<br>K070541 | Zeobi<br>K121338 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | Adjunctive use in the<br>palliative treatment of post-<br>operative pain and edema in<br>superficial soft tissue | Adjunctive use in the<br>palliative treatment of post-<br>operative pain and edema in<br>superficial soft tissue |
| Carrier Frequency | 27.12 MHz | 27.12 MHz |
| Burst Duration | 2 msec | 2 msec |
| Burst Repetition | 2 Hz | 2 Hz |
| Energy Density | $0.13 \pm 0.02 \mu$ Ws/cm³ | $0.13 \pm 0.02 \mu$ Ws/cm³ |
| Electrical Safety | Conforms with IEC 60601-1 | Conforms with IEC 60601-1 |
| Electromagnetic safety | Conforms with IEC 60601-1-2 | Conforms with IEC 60601-1-2 |
| Power Supply | In-Circuit Battery Source:<br>Primary Lithium Coin Cell<br>Batteries (2) | Detachable Battery Pack:<br>Primary Lithium Coin Cell<br>Batteries (2) |
| User Display | LED Display with two green<br>lights | Multi-Function LCD Display |
| Treatment Modes | • Automatic mode: 6<br>treatments per for three<br>days, 3 treatments per day<br>for 3 days and 2 treatments<br>per day until shut off or<br>battery depletes<br>• Manual mode: user<br>activated | • Automatic mode: 12<br>treatments every two hours<br>until the unit is shut off or<br>battery depletes<br>• Manual mode: user<br>activated |
| Treatment Time | Maximum of 30 minutes | Maximum of 15 minutes |

Performance bench testing was performed on carrier frequency, burst duration, burst repetition and energy density (relative power measurement). Testing of carrier frequency, burst duration and burst repetition was done with a calibrated high frequency probe/oscilloscope system. For the energy density test measurement of power was performed in a validated saline load with a calibrated spectrum analyzer via a calibrated inline attenuator.

Standards Met:

- . IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2 Medical Electrical Equipment Part 2: . General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests

Conclusion: The Zeobi is identical to the Torino II in terms of its indications for use and intended use.

The Zeobi is substantially equivalent to the Torino II in terms of technical specifications, operating performance features, and general design features.